Early clinical trial rate slowing in Asia despite obvious advantages

SINGAPORE – Despite a number of advantages as a site for early stage clinical trials, Asia not only lags other regions in the world but the proportion of studies it hosts is actually dropping.

The number of early stage clinical trials carried out in Asia has remained roughly constant over the past few years, but its global percentage has declined. South Korea, for example, was home to about 5 percent of early stage global trials in 2011, but the percentage dropped to 4 percent by 2014.

"Unlike the broader clinical research enterprise, early stage clinical studies in Asia are not moving forward at the same pace as the rest of the world," James Garner, head of unit development operations for Asia R&D at Sanofi SA, said during the 2015 BioPharma Asia Convention at Suntec Singapore on Tuesday. "They're not moving to Asia as the same way later-stage clinical trials have been doing."

A number of Asian countries, not least among them South Korea, are trying to attract more early stage trials, which are cheaper but riskier to conduct.

When a drug enters phase I, it has just a 5 percent chance of achieving technical success, but that chance jumps to 50 percent at later stages, so the early stage studies are a transformative period in terms of the economics of a drug.

"It benefits both the industry and the countries to bring early stage clinical studies to Asia," Garner said. "Asia has the resources and capacity of the infrastructure to do this kind of work.

"If you pick the right indication and centers, there's a potential to recruit patients faster, particularly when we look at oncology studies where we go directly into patient population," he added. "Asia's ability to rapidly recruit patients in these studies can be very important."

From a pharmaceutical company's point of view, there are several advantages to doing more early stage clinical studies in Asia. A first set of advantages is regulatory.

Countries such as China and Japan make it a necessity to conduct phase I studies in country. In Taiwan, doing the studies domestically can lead to reimbursement advantages that yield price premiums.

Another important set of advantages is patient access, particularly when it comes to relatively niche populations such as oncology patients that may be harder to find in the West. Time savings in that area can also be a huge advantage for pharmaceutical companies that do their early stage clinical studies in Asia.

Lower costs are also an upside. Asia has plenty of world-class clinical centers and well-established infrastructure to carry out early stage studies, which also are often cheaper. Clinical research organizations (CROs) from Asia often cost half as much as their peers in the U.S.

The ability to access patients who have not been heavily pre-treated with other therapies is another important advantage in Asia, particularly for molecularly targeted oncology treatment. It can affect the success of the clinical trials fundamentally.

Yet despite those advantages, companies, clinicians and health systems continue to experience challenges in bringing early stage trials to Asia. There are scientific concerns about how well the results are generated in the region. Patient awareness and regulatory complexity are also issues that can impede early stage trials.

The patients in Asia are more cautious and there are also regulatory challenges. Exporting of DNA-containing samples is very hard in China and Indonesia. First-in-human studies are prohibited in China and India.

Another issue may be more basic and have to do with physiology. In oncology, for example, tumor types differ profoundly between countries and even for a particular tumor type the underlying pathology can be different in Asian patients. In addition, the standard of care can vary significantly between Asia and the West so some of the Western pharmaceutical companies are reluctant to conduct such clinical trials in Asia.

Still, motivated by the potential to access cutting-edge technology a bit earlier, countries in Asia are making a push to attract more early stage trials. That push is particularly visible in South Korea.

"The reason why South Korea is so focused on the domestic companies doing investigator-initiated trials is that they want to boost their credibility as scientists, so there's a big push in terms of early stage research in the country as well as multinational companies bringing such studies to South Korea," said Anthony Nguyen, director of business and project acceleration team at Dong-A University Hospital Global Clinical Trial Center.

"Population, education and government support are fueling the growth of this sector," he noted.

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